An aim of modern medicine is to provide personalized or individualized treatment regimens. Those are treatment regimens which take into account a patient's individual needs or risks. Hyperproliferative disorders have in many cases a severe impact on the human or animal physiology. Many severe diseases, such as cancer, are caused by undesired, enhanced proliferation of cells. Specifically, cancer diseases comprise some of the most life threatening medical conditions, such as lung carcinomas which belong to the leading causes of human cancer death.
Various approaches for cancer therapy exist, e.g., surgery, chemotherapy, radiation therapy, and immunotherapy. A new, very promising cancer therapy is anti-angiogenesis therapy. The principle underlying anti-angiogenesis therapy is that tumors can grow only if new blood vessels are being formed within the blood vessels. By stopping the growth of blood vessels within the tumors with angiogenesis inhibitors, the means by which tumors can extend themselves and spread inside the body are significantly reduced. Administration of the angiogenesis inhibitor Bevacizumab (Avastin) was the first U.S. Food and Drug Administration (FDA)-approved biological therapy designed to inhibit the formation of new blood vessels in tumors. Bevacizumab itself is a monoclonal antibody against the vascular endothelial growth factor (VEGF). It was shown, e.g., that Bevacizumab significantly improves survival in metastatic colorectal cancer. The FDA has also approved other anti-angiogenic pharmaceuticals for cancer therapy, e.g. for multiple myeloma, mantle cell lymphoma, gastrointestinal stromal tumors, and kidney cancer. More anti-angiogenesis cancer therapies are awaiting approval.
The great beneficial effects of treating cancer patients with anti-angiogenic drugs, however, are being hampered by some problems. There is evidence that a therapy which inhibits new vessel formation has adverse side effects (particularly cardiovascular complications) and, therefore, may put some patients at risk. Accordingly, it was shown that, e.g., sorafenib induces acute coronary syndromes in 2.9% of patients treated with sorafenib (2007, Annals of Oncology, Volume 18. No. 11, 1906-1907).
Therefore, measures and means are required in order to (i) identify those subjects that are susceptible to a therapy with anti-angiogenic drugs and to (ii) identify those subjects which would be at elevated risk of heart failure and/or acute cardiovascular events as a consequence of a future intake of anti-angiogenic drugs.
However, such means and measures have not been described yet. Thus, the technical problem underlying the present invention can be seen as the provision of means and methods for complying with the aforementioned needs.
The technical problem is solved by the embodiments characterized in the claims and herein below.